FDA issues final guidance revising blood donor deferral recommendations

The Food and Drug Administration today issued final guidance revising blood donor deferral recommendations for individuals at increased risk for transmitting HIV. Since September 1985, FDA has recommended that blood establishments indefinitely defer male donors who have had sex with another male at least once since 1977, in part due to high HIV infection rates in that population. The final guidance changes the blood donor deferral period from indefinite deferral to one year since the last sexual contact, among other changes. It also recommends that blood establishments make corresponding revisions to donor educational materials and history questionnaires, as well as donor requalification and product management procedures.